The New Drug Approval Process: Basic Concepts

Recognize the difference between a “drug” and a “new drug” under the Federal Food Drug and Cosmetic Act (FDCA). Learn the various approval pathways for bringing a new drug to the U.S. market. Understand the scientific standards by which FDA will approve a new drug.

Jason F. Conaty, Counsel, Global Regulatory, Hogan Lovells US LLP

This session was recorded as part of FDLI’s Introduction to Drug Law and Regulation Course in November 2023. 

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